510(k) K050221

HEMOSIL SILICA CLOTTING TIME by Instrumentation Laboratory CO — Product Code GFO

K050221 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL SILICA CLOTTING TIME". The FDA issued a decision of Substantially Equivalent on March 30, 2005. The device falls under product code GFO (Activated Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.